Organon Remeron Phase IV trial to look at somnolence in dose-response study of antidepressant.

Executive Summary

ORGANON REMERON PHASE IV TRIAL TO EXAMINE SOMNOLENCE in a dose-response trial, according to FDA's June 14 approval letter for Remeron (mirtazapine). Organon has agreed to conduct "a fixed dose response/somnolence study that will explore dose response for both antidepressant effectiveness and for somnolence," the letter states. "We also note your commitment to initiate this study in early 1997 and to complete this study by mid-1998." Remeron is the first alpha-2 receptor antagonist antidepressant approved in the U.S. ("The Pink Sheet" June 17, T&G-1).